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A Study of Continuous Oral Contraceptives and Doxycycline

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00480532
Recruitment Status : Completed
First Posted : May 31, 2007
Results First Posted : January 28, 2013
Last Update Posted : October 22, 2014
Sponsor:
Information provided by (Responsible Party):
Jeffrey Jensen, Oregon Health and Science University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Contraceptives, Oral
Interventions Drug: Lybrel
Drug: Doxycycline
Drug: Oracea
Drug: Placebo
Drug: Doxycycline 100bid x5 days at the time of bleeding
Drug: Subantimicrobial doxycycline daily
Drug: placebo daily
Enrollment 131
Recruitment Details Recruitment at Oregon Health and Science University (OHSU) and University of Hawaii (UH
Pre-assignment Details  
Arm/Group Title Placebo (Treatment) Doxy (7 Day Treatment Arm) Placebo (Prevention) Subantibmicrobial Dose Doxy
Hide Arm/Group Description Placebo (for treatment portion of the study) Doxycycline 100 mg po bid x 7 days taken when bleeding occurred Placebo for prevention portion of the study Doxycycline 40mg (sustained release) once daily for 84 days
Period Title: Overall Study
Started 33 33 33 32
Completed 31 29 29 31
Not Completed 2 4 4 1
Reason Not Completed
Withdrawal by Subject             2             4             3             1
Protocol Violation             0             0             1             0
Arm/Group Title Placebo (Treatment) Doxy (7 Day Treatment Arm) Placebo (Prevention) Subantibmicrobial Dose Doxy Total
Hide Arm/Group Description Placebo (for treatment portion of the study) Doxycycline 100 mg po bid x 7 days taken when bleeding occurred Placebo for prevention portion of the study Doxycycline 40mg (sustained release) once daily for 84 days Total of all reporting groups
Overall Number of Baseline Participants 33 33 33 32 131
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 33 participants 33 participants 32 participants 131 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.1%
1
   0.8%
Between 18 and 65 years
33
 100.0%
33
 100.0%
33
 100.0%
31
  96.9%
130
  99.2%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 33 participants 33 participants 32 participants 131 participants
28.0  (6.6) 27.5  (6.8) 27.8  (5.4) 28.6  (6.1) 28.0  (7.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 33 participants 33 participants 32 participants 131 participants
Female
33
 100.0%
33
 100.0%
33
 100.0%
32
 100.0%
131
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 33 participants 33 participants 33 participants 32 participants 131 participants
33 33 33 32 131
1.Primary Outcome
Title Differences in Bleeding Patterns Between Study Groups.
Hide Description number of days of bleeding and spotting, self reported on calendar
Time Frame The outcome was also assessed for day 1 to 84
Hide Outcome Measure Data
Hide Analysis Population Description
All participants analyzed in the groups to which they were randomized except for 1 subject in prevention placebo group who was erroneously enrolled although she did not meet enrollment entry criteria
Arm/Group Title Placebo (Treatment) Doxy (7 Day Treatment Arm) Placebo (Prevention) Subantibmicrobial Dose Doxy
Hide Arm/Group Description:
Placebo (for treatment portion of the study)
Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
Placebo for prevention portion of the study
Doxycycline 40mg (sustained release) once daily for 84 days
Overall Number of Participants Analyzed 33 33 32 32
Mean (Standard Error)
Unit of Measure: days
26.72  (4.89) 31.86  (5.08) 25.69  (3.24) 18.84  (3.30)
2.Secondary Outcome
Title Subject Satisfaction.
Hide Description measured using 100 mm visual analog scale. anchors of "not at all satisfied" (0mm) "extremely satisfied" (100mm)
Time Frame Assessed on day 112 of the study (the end of the study period). This outcome does not represent a change from baseline. It was assessed at the end of the study period.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo (Treatment) Doxy (7 Day Treatment Arm) Placebo (Prevention) Subantibmicrobial Dose Doxy
Hide Arm/Group Description:
Placebo (for treatment portion of the study)
Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
Placebo for prevention portion of the study
Doxycycline 40mg (sustained release) once daily for 84 days
Overall Number of Participants Analyzed 33 33 32 32
Mean (Standard Deviation)
Unit of Measure: mm
63.9  (41.1) 64.2  (33.0) 72.0  (30.9) 67.0  (35.3)
3.Secondary Outcome
Title Subject Compliance
Hide Description measured by self report of pill intake on daily diary (yes/no), and reported as percentage with no missed pills over entire study
Time Frame Assessed on day 112 of the study (the end of the study period). The outcome reflects the number of subjects who did not miss pills during the entire 112 day study. It does not represent a change from baseline.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo (Treatment) Doxy (7 Day Treatment Arm) Placebo (Prevention) Subantibmicrobial Dose Doxy
Hide Arm/Group Description:
Placebo (for treatment portion of the study)
Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
Placebo for prevention portion of the study
Doxycycline 40mg (sustained release) once daily for 84 days
Overall Number of Participants Analyzed 33 33 32 32
Measure Type: Number
Unit of Measure: number of participants with no missed pi
25 21 19 20
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo (Treatment) Doxy (7 Day Treatment Arm) Placebo (Prevention) Subantibmicrobial Dose Doxy
Hide Arm/Group Description Placebo (for treatment portion of the study) Doxycycline 100 mg po bid x 7 days taken when bleeding occurred Placebo for prevention portion of the study Doxycycline 40mg (sustained release) once daily for 84 days
All-Cause Mortality
Placebo (Treatment) Doxy (7 Day Treatment Arm) Placebo (Prevention) Subantibmicrobial Dose Doxy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo (Treatment) Doxy (7 Day Treatment Arm) Placebo (Prevention) Subantibmicrobial Dose Doxy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/33 (0.00%)   0/32 (0.00%)   0/32 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo (Treatment) Doxy (7 Day Treatment Arm) Placebo (Prevention) Subantibmicrobial Dose Doxy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/33 (0.00%)   0/32 (0.00%)   0/32 (0.00%) 
Treatment Arm: Subjects had difficulty understanding when to start and stop treatment.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bliss Kaneshiro
Organization: University of Hawaii (UH)
Phone: 808-203-6500
EMail: bkaneshiro@ucera.org
Layout table for additonal information
Responsible Party: Jeffrey Jensen, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00480532    
Other Study ID Numbers: OHSU FAMPLAN 2907
First Submitted: May 30, 2007
First Posted: May 31, 2007
Results First Submitted: May 21, 2012
Results First Posted: January 28, 2013
Last Update Posted: October 22, 2014